NCT05532319

HAIC Sequential TAE Combined With Lenvatinib and Tislelizumab in Unresectable HCC

Phase II Trial of Hepatic Arterial inFusion Chemotherapy Sequential transaRterial Embolization cOmbined With leNvatinib and Tislelizumab in Unresectable Hepatocellular Carcinoma (FRONT Trial)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Guangxi Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Patients with unresectable hepatocellular carcinoma will receive hepatic arterial infusion chemotherapy (HAIC) sequential transarterial embolization combined with lenvatinib and tislelizumab.

Detailed description

In recent years, more and more studies have found that the efficacy of hepatic arterial infusion chemotherapy (HAIC) alone or combined with targeted drugs (such as lenvatinib) in the treatment of advanced HCC is significantly better than that of targeted monotherapy. The principle of HAIC is that chemotherapeutic drugs are continuously pumped through the hepatic artery through a microcatheter, thereby killing tumor cells and causing tumor shrinkage and necrosis. Although continuous infusion of chemotherapeutic drugs through the hepatic artery can significantly improve the local drug concentration in the tumor, and reduce the toxic and side effects of drugs on the whole body while improving the therapeutic effect, the effect of HAIC is slow. The blood supply of HCC is 95%-99% from the hepatic artery, and abundant blood supply is conducive to the continuous growth of HCC. If transarterial embolization (TAE) can be used to block the blood supply of HCC immediately after HAIC treatment, theoretically, it should further promote the effect of HAIC on tumor cell necrosis, make the tumor quickly reach PR or even CR, obtain the opportunity of hepatic resection, and finally prolong patients' survival time. However, there is still a lack of literature reports on HAIC sequential TAE in the treatment of advanced HCC. Therefore, this project intends to carry out a prospective phase II clinical study to explore the safety and efficacy (ORR, DOR, PFS, OS) of HAIC sequential TAE combined with targeted (lenvatinib) and immunotherapy (tislelizumab) quadruplets, and to screen the best benefit population.

Conditions

• Liver Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	HAIC sequential TAE combined with lenvatinib and tislelizumab	Patients with unresectable hepatocellular carcinoma will receive hepatic arterial infusion chemotherapy (HAIC) sequential transarterial embolization combined with lenvatinib and tislelizumab.

Timeline

• Start date: 2022-11-10
• Primary completion: 2025-12-23
• Completion: 2025-12-23
• First posted: 2022-09-08
• Last updated: 2025-12-30

Locations

1 site across 1 country: China